Galveston, TX—A substantial percentage of the men filling scripts for androgen replacement therapy may never have had their hormone levels tested, and, even among those who were tested, results may not have indicated that their testosterone levels were too low.

That’s according to
a new study from researchers at the University of Texas Medical Branch. The study, which documents the significant increase in testosterone therapy in the last decade, was published in JAMA Internal Medicine.

The research letter notes that “...from 2001 through 2011, androgen use among men 40 years or older increased more than threefold, from 0.81% in 2001 to 2.91% in 2011. The increase was seen in all age groups.”

As a result, the authors add, “By 2011, 2.29% of men in their 40s and 3.7% of men in their 60s were taking some form of ART.”

While about half of the men in the study who received testosterone therapy had a diagnosis of hypogonadism, researchers found that about 25% of new users of prescription androgen therapy overall had not had hormone levels tested before initiating treatment. They also note that it was unclear how many of the patients who had been tested and began therapy actually had low levels of testosterone.

Researchers used information from Clinformatics DataMart, one of the nation’s largest commercial health insurance populations, to review records for more than 10 million men age 40 and over.

Lead author Jacques Baillargeon, PhD, associate professor in preventive medicine and community health at UTMB, suggested this was the first national population-based study of testosterone-prescribing patterns.

“This trend has been driven, in large part, by direct-to-consumer marketing campaigns that have targeted middle-aged men and the expansion of clinics specializing in the treatment of low testosterone—or ‘low-T centers,’” Baillargeon said.

The upsurge in prescriptions, according to the authors, also was tied to the development of new drugs and even improved delivery mechanisms; the research indicated that use of topical gels went up the most—increasing fivefold.

Calling for more research, Baillargeon said the study is significant because there is conflicting data on the short- and long-term risks of testosterone therapy, especially related to cardiovascular issues and prostate cancer.

In 2010, according to the study, the highest prevalence of androgen prescriptions was in the South, where the products were used by 3.77% of men over 40.